Quality Training Specialist: FDA QMS & CAPA Expert

Bertelsmann-Jobs; Pleasant Prairie (WI); On-site; USD 60,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life Insurance

AD&D coverage

Paid time off

Employee assistance program

Ongoing training opportunities

Job summary

Arvato is a leading 3PL provider seeking a Training & Quality Specialist to support FDA quality systems, training programs, and CAPA processes at our Wisconsin facility. You will manage documentation, conduct training, and ensure audit readiness while coordinating with process owners and QA teams.

The role requires strong organizational skills, proficiency with MS Office, and the ability to facilitate group sessions.

Qualifications

• Knowledge of FDA quality system requirements, document control, training records, audit readiness, CAPA, complaint handling, and quality record retention.
• Proficient in Microsoft Office programs and training technology platforms.
• Excellent written and verbal communication skills.
• Understanding of training and quality processes, including program development.
• Ability to facilitate moderate to large group sessions.
• Highly organized and detail-oriented, with the ability to independently manage projects and programs.

Responsibilities

• Review process documents and update training Curriculum, as needed.
• Train employees on training processes and conduct first-day orientation.
• Maintain training matrix and reporting tools; assist in identifying opportunities for process improvement.
• Support FDA documentation, CAPA, complaints, labeling, and audit readiness.
• Administer SharePoint Document and Training Center systems; support LEAN initiatives.
• Assist with audit readiness activities and tracking audit findings.
• Track Training and Quality Department KPIs and objectives.

Job description

Arvato is a leading 3PL provider seeking a Training & Quality Specialist to support FDA quality systems, training programs, and CAPA processes at our Wisconsin facility. You will manage documentation, conduct training, and ensure audit readiness while coordinating with process owners and QA teams.

The role requires strong organizational skills, proficiency with MS Office, and the ability to facilitate group sessions.